MAUDE Adverse Event Report: BOSTON SCIENTIFIC/NORTECH SYSTEMS, INC. REZUM SYSTEM ; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Death (1802); Myocardial Infarction (1969); Pain (1994)

Event Date 09/13/2019

Event Type  Death  

Event Description

Reporter who is a registered nurse is reporting on behalf of her father; called to report that he has had three myocardial infarctions and one stroke the following day of having a benign prostate hyperplasia procedure with the use of rezum.Reporter states that her father told her after the procedure that it was extremely painful and would not have done this type of procedure if he had known that it was as painful as it was.Also, this type of procedure was recommended by his doctor because of his history of heart disease."my father had to start hospice on (b)(6) 2019 and he died on (b)(6) 2019''.

• Brand Name: REZUM SYSTEM
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC/NORTECH SYSTEMS, INC.
• MDR Report Key: 9321730
• MDR Text Key: 166531533
• Report Number: MW5091071
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 85 YR
• Patient Weight: 78